Evidence map›Paper›PMID 38225546›Full record

ArticleBMC infectious diseases2024

Development and clinical application of loop-mediated isothermal amplification combined with lateral flow assay for rapid diagnosis of SARS-CoV-2.

Jin Tang, Jie Zhu, Jie Wang, Haiyong Qian, Zengxin Liu, Ru Wang, Qingqing Cai, Yuan Fang, Weifeng Huang

Abstract read
In one paragraph

Article in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Rapid Visual Detection ofJournal of fungi (Basel, Switzerland) · 2026
    Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jin Tang *Department of Clinical Laboratory, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Jie Zhu *Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Jie Wang *Shanghai Fengxian District Central Hospital, Shanghai, 201406, China.
Haiyong QianDepartment of Intensive Care Medicine, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.
Zengxin LiuGenoxor Medical Science and Technology Inc., No 555 Wangfang Road, Minhang District, Shanghai, 201112, China.
Ru WangGenoxor Medical Science and Technology Inc., No 555 Wangfang Road, Minhang District, Shanghai, 201112, China.
Qingqing CaiGenoxor Medical Science and Technology Inc., No 555 Wangfang Road, Minhang District, Shanghai, 201112, China.
Yuan FangGenoxor Medical Science and Technology Inc., No 555 Wangfang Road, Minhang District, Shanghai, 201112, China. yuan.fang@genoxor.com.
Weifeng HuangDepartment of Intensive Care Medicine, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China. breeze-huang@hotmail.com.

Funding

Shanghai Sixth People's Hospital ynxg202205
6 · The paper itself

Abstract

backgroundThe diagnostic assay leveraging multiple reverse transcription loop-mediated isothermal amplification (RT-LAMP) could meet the requirements for rapid nucleic acid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

methodsThe devised assay merged the lateral flow assay with the RT-LAMP technology and designed specific primers for the simultaneous detection of the target and human-derived internal reference genes within a single reaction. An inquiry into the assay's limit of detection (LOD), sensitivity, and specificity was carried out. The effectiveness of this assay was validated using 498 clinical specimens.

resultsThis LOD of the assay was determined to be 500 copies/mL, and there was no observed cross-reaction with other respiratory pathogens. The detection results derived from clinical specimens showed substantial concordance with those from real-time reverse transcription-polymerase chain reaction (RT-qPCR) (Cohen's kappa, 0.876; 95% CI: 0.833-0.919; p<0.005). The diagnostic sensitivity and specificity were 87.1% and 100%, respectively.

conclusionThe RT-LAMP assay, paired with a straightforward and disposable lateral immunochromatographic strip, achieves visual detection of dual targets for SARS-CoV-2 immediatly. Moreover, the entire procedure abstains from nucleic acids extraction. The samples are lysed at room temperature and subsequently proceed directly to the RT-LAMP reaction, which can be executed within 30 minutes at a constant temperature of 60-65°C. Then, the RT-LAMP amplification products are visualized using colloidal gold test strips.

trial registrationThis study was registered at the Chinese Clinical Trial Registry (Registration number: ChiCTR2200060495, Date of registration 2022-06-03).

Indexed as

COVID-19SARS-CoV-2COVID-19 TestingHumansMolecular Diagnostic TechniquesNucleic Acid Amplification TechniquesRNA, ViralSensitivity and SpecificityRNA, ViralCOVID-19DiagnosticsIsothermal amplificationMolecular testingRT-LAMPSARS-CoV-2

Identifiers

PMID38225546
PMCPMC10788970

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.